Identity
- Trade Name
- OptiFlow II Flowable Composite EUDAMED
- Device Name
- OptiFlow II Flowable Composite EUDAMED
- Model / Reference
- 48213 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00818746024651 EUDAMED
- Basic UDI-DI
- 081874602480000H7 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
OptiFlow II Flowable Composite by The Belport Company, Inc. DBA Gingi-Pak — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081874602480000H7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- The Belport Company, Inc. DBA Gingi-Pak
- EUDAMED SRN
- US-MF-000044279
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (1)
- EUDAMED 1c9fe1eb-5efc-4e52-85e7-41361b6a3bb4 61 fields · synced Jun 19, 2026